Editor's Pick: Markets: Metal prices bolster FTSE 100
(LPX.L) Lipoxen PLC Buy/Sell
Add to portfolio Set Alert Level 2 Desktop Trader
Summary
|
|
|||||||||||||||||||||||||||||||||||||||||||
|
|
|
||||||||||||||||||||||||||||||||||||||||||
| Date/Time | Headline | Source |
|---|---|---|
| 16-11-09 | RNS |
|
|
RNS Number : 5321C Lipoxen PLC 16 November 2009 For immediate release 16 November 2009 Lipoxen plc ('Lipoxen' or 'the Company') New Research Collaboration with Pharmsynthez ~ Six candidates to be clinically validated utilising ImuXen or PolyXen ~ Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and siRNA delivery, is pleased to announce that it has signed a collaboration agreement (the "Agreement") with Pharmasynthez ZAO ("Pharmsynthez"), a leading Russian private research-based pharmaceutical company, to apply Lipoxen's ImuXen and PolyXen proprietary technologies to a broad range of six drug and vaccine candidates in collaboration with Pharmsynthez. Lipoxen will provide scientific supervision to Pharmsynthez for candidate optimisation and clinical proof of concept trials will be funded by Pharmsynthez. Lipoxen will have access to all relevant clinical data arising from the subsequent clinical trials. Highlights of the Agreement
Under the Agreement, Pharmsynthez will apply Lipoxen's ImuXen technology to create three enhanced vaccine candidates for secondary progressive multiple sclerosis, HIV and non-Hodgkin's lymphoma. Similarly, Lipoxen's PolyXen technology will be applied to active compounds to create three pharmaceutical candidates for treatment of cystic fibrosis, acute myeloid leukaemia, non-Hodgkin's lymphoma and type 2 diabetes. Scientists from Pharmsynthez will optimise the candidates with guidance from Lipoxen and will complete testing to achieve clinical proof of principle the end of 2010. Candidates that show promise, as determined by a Programme Committee, will then progress to full-scale clinical development in Europe and the United States. Secondary progressive multiple sclerosis, cystic fibrosis ,non-Hodgkin's lymphoma and acute myeloid leukaemia are all rare diseases and candidates that are progressed for these indications could be eligible for an abbreviated clinical pathway under EMEA and FDA regulations and market exclusivity for ten years and seven years respectively. Lipoxen will have the right to use all relevant data from the clinical trials to conduct further trials and seek marketing authorisation in other world territories. As a result of the Agreement, Lipoxen will receive royalties of 10% of all net sales from Pharmsynthez should the products progress through clinical development and be approved for marketing in the Russian Federation. A Programme Committee, to be chaired by Lipoxen, will be formed to progress the Agreement which will comprise representatives from both Lipoxen and Pharmsynthez. Any arising intellectual property will be jointly owned by the two parties, unless it relates solely to Lipoxen's platform technologies. ImuXen is an advanced platform vaccine delivery technology that employs novel liposome constructs to boost the effectiveness of DNA, protein and polysaccharide vaccines. PolyXen is a multifaceted platform technology that employs polysialic acid to prolong the active life of the drug in the body and improve the effectiveness of the drugs. Commenting on the Agreement, M. Scott Maguire, CEO of Lipoxen, said: "We are very pleased to be working with Pharmsynthez to apply our ImuXen and PolyXen platform technologies to Pharmsynthez's compounds in multiple sclerosis, HIV and non-Hodgkin lymphoma as well as cystic fibrosis, acute myeloid leukemia and type 2 diabetes. Given that the commitment of upfront resources is limited to sharing our scientific knowledge of our propriety platform technologies, Lipoxen is particularly pleased to have access to the clinical data from these trials which will put it in a strong position to decide whether to run EMEA and FDA trials on the candidates to achieve marketing approval in other world territories. "In addition, achieving human clinical proof of concept for these products further validates our ImuXen and PolyXen platform technologies and the clinical data produced will support the utility of these broadly applicable technologies to enhance existing propriety compounds, which forms an important part of our business model."
For further information please contact:
M. Scott Maguire, Chief Executive Officer
Jeff Keating / Claes Sp?
John Llewellyn-Lloyd / Sam Reynolds
Lisa Baderoon, Catherine Breen Notes for Editors About Lipoxen Lipoxen plc is a biopharmaceutical company focused on the development of new and improved biologic drugs and vaccines. Lipoxen has three proprietary patented technology platforms: 1) PolyXen - for extending the efficacy and half life of biologic drugs 2) ImuXen - for creating new vaccines and improving existing vaccines 3) SiRNAblate - for the delivery of siRNA Lipoxen's technology is designed to improve the efficacy, safety, stability, biological half-life and immunologic characteristics of its products. Lipoxen has multiple drug and vaccine programmes in development. Two products are in clinical development, SuliXen, a long acting insulin and ErepoXen, a long-acting erythropoietin (EPO). Lipoxen's preclinical pipeline includes vaccines against HIV, influenza and malaria. Also Lipoxen has an exclusive license with Baxter International, a leading global healthcare company, for utilizing PolyXen with Factor VIII. Total milestone payments could reach $75M plus royalties on sales. The Company has a low-risk business model and out-licenses its proprietary technologies to biopharmaceutical companies that have strong manufacturing and marketing capabilities. Lipoxen currently has commercial agreements with some of the world's leading biotechnology and pharmaceutical companies including Baxter, Schering-Plough, Sanofi-Aventis, the Serum Institute of India Limited, Genentech, Amgen and Genzyme. Furthermore, Baxter led the £2.9 million fundraising that the Company announced in May 2009, with a US$1 million investment. Serum Institute of India and Baxter are currently the second and third largest shareholders in Lipoxen. Lipoxen, which was founded in 1997, now trades on the AIM Market of the London Stock Exchange under the ticker symbol LPX. More information can be found at the Company's website: www.lipoxen.com. About Pharmsynthez Pharmsynthez ZAO is a leading Russian private pharmaceutical research-based company and offer high quality chemical and analytical development of investigational medicinal products. It is one of the major companies operating in this segment of the Russian market. Currently the company manufactures and markets drugs for the treatment of cancer, tuberculosis, and infection diseases. For more information, please visit the company's website: www.pharmsynthez.com. This information is provided by RNS The company news service from the London Stock Exchange END
AGRKELFFKFBZFBX More |
||
| 10-11-09 | RNS |
|
|
RNS Number : 2637C Lipoxen PLC 10 November 2009 Lipoxen PLC ("Lipoxen" or "the Company") Additional listing London, UK, 10 November 2009 - Lipoxen PLC (AIM:LPX) a bio-pharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and siRNA delivery, announces that application has been made to AIM, a market of the London Stock Exchange plc, for the admission of 187,145 ordinary shares of 0.5p each (the "New Ordinary Shares"). The New Ordinary Shares are being admitted pursuant to the exercise of options under the Lipoxen Plc Unapproved Share Option Plan. It is expected that dealings in the New Ordinary Shares, which will rank pari passu in all respects with the existing issued share capital of the Company, will commence on 11 November 2009. Enquiries
M. Scott Maguire, Chief Executive Officer
Jeff Keating / Claes Sp?
John Llewellyn-Lloyd / Sam Reynolds
Lisa Baderoon, Rebecca Skye Dietrich, Catherine Breen This information is provided by RNS The company news service from the London Stock Exchange END
LISEANFEFSLNFEE More |
||
| 01-10-09 | RNS |
|
|
RNS Number : 0833A Lipoxen PLC 01 October 2009 Lipoxen PLC ("Lipoxen" or "the Company") Additional listing and Total Voting Right London, UK, 1 October 2009 - Lipoxen PLC (AIM:LPX) a bio-pharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and siRNA delivery, announces that application has been made to AIM, a market of the London Stock Exchange plc, for the admission of 100,000 ordinary shares of 0.5p each (the "New Ordinary Shares"). The New Ordinary Shares are being admitted pursuant to the exercise of options under the Lipoxen Plc Unapproved Share Option Plan. It is expected that dealings in the New Ordinary Shares, which will rank pari passu in all respects with the existing issued share capital of the Company, will commence on 2 October 2009. In conformity with the FSA's Disclosure and Transparency Rules, the Company notifies the market of the following: Following the admission to trading on AIM of the Ordinary Shares mentioned above Lipoxen's capital consists of 154,210,085 ordinary shares of 0.5p each ("Ordinary Shares") with voting rights. No Ordinary Shares are held in treasury, therefore the total number of voting rights in the Company is 154,210,085. The above figure (154,210,085) may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, Lipoxen under the FSA's Disclosure and Transparency Rules.
Enquiries
M. Scott Maguire, Chief Executive Officer
Jeff Keating / Claes Sp?
John Llewellyn-Lloyd / Sam Reynolds
Mary-Jane Elliott, Lisa Baderoon, Rebecca Skye Dietrich, Catherine Breen This information is provided by RNS The company news service from the London Stock Exchange END
IOEBSBDGRGGGGCB More |
||
| 30-09-09 | RNS |
|
This news article is displayed preformatted as it may contain results tables
RNS Number : 9581Z
Lipoxen PLC
30 September 2009
For Immediate Release 30 September 2009
Due to technical formatting problems with RNS, Lipoxen's Interim Results statement was issued with incomplete financial information. Specifically, some figures were missing from the Condensed Consolidated Statement of Changes in Net Equity table. The statement below contains the completed information and replaces RNS Number: 9114Z.
Lipoxen PLC
("Lipoxen" or "the Company")
Interim Results for the six months ended 30 June 2009
London, UK - Lipoxen PLC (AIM:LPX), a bio-pharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and siRNA delivery, is pleased to announce its interim results for the six months ended 30 June 2009.
Key Operational Highlights:
* ErepoXen - a long-acting erythropoietin (EPO):
- Successful completion of Phase I trials
- Candidate to be fast tracked to a full Phase II program
* SuliXen - a long acting insulin:
- Successful completion of Phase I trials
- Phase II trials now expected to commence in Russia in early Q4-09
* ImuXen - platform liposomal technology
- Preclinical feasibility project agreement signed with the PATH Malaria
Vaccine Initiative and the US National Institute of Allergy and Infectious
Diseases to stimulate enhanced immune responses against malaria protein
- Commencement of ImuXen HIV vaccine formulation project funded by the Bill and
Melinda Gates International Aids Vaccine Initiative in Q2-09
- New Co-Delivery DNA Vaccine Patent granted in EU and US
* siRNAblate - gene silencing platform technology:
- New Technology Evaluation Agreement signed with leading global pharmaceutical
company
* Appointed lead member of the grant consortium for its controlled-release nanoparticle vaccine
program, which includes the Company's H1N1 influenza project, by the UK Government's Technology
Strategy Board on 29 September 2009
* Dr David Moss appointed as Director of Project Management in September 2009 to drive forward
Lipoxen's projects
Key Financial Highlights:
* Placing completed in May 2009 raising £2.9m before expenses, led by
cornerstone
investor and partner, Baxter International Inc.
* Turnover of £0.41 m (2008: £0.42 m)
* Pre-tax loss of £1.43 m (2008: £1.96 m)
* Non-cash component of total pre-tax loss £0.22 m (2008: £0.89 m)
* Net cash at period end of £2.8 m (2008: £1.21 m)
* Net asset value £4.3 m (2008: £4.6m)
* Loss per share basic and fully diluted of 1.14 p (2008: 1.51 p)
* Net asset value per share - basic 2.78 p (2008: 3.84 p)
* Net asset value per share - fully diluted 2.69 p (2008: 3.65 p)
Commenting on the results, M. Scott Maguire, CEO of Lipoxen, said:
"Against a backdrop of very difficult economic conditions, we are delighted that Lipoxen was able to complete a significant fundraising of £2.9m before expenses. The fundraising, which was led by our cornerstone investor, Baxter International Inc., demonstrates the confidence that our partners have in our core technologies and their applications. Lipoxen has continued to work successfully with, and sign new partnerships with, a number of world class organisations, including PATH Malaria Vaccine Initiative, the US National Institute of Allergy and Infectious Diseases and the Bill and Melinda Gates International Aids Vaccine Initiative.
"We look forward to delivering further tangible progress on all of our projects and the Board remains confident that its corporate goals remain achievable in time frames consistent with the nature of the business."
For further information:
Lipoxen PLC +44 (0)20 7691 3583
M. Scott Maguire, Chief Executive Officer
Singer Capital Markets (nominated adviser) +44 (0)20 3205 7500
Jeff Keating / Claes Sp?
Noble & Co +44 (0)20 7763 2200
John Llewellyn-Lloyd / Sam Reynolds
Buchanan Communications +44 (0)20 7466 5000
Lisa Baderoon, Catherine Breen
Notes to Editors
About Lipoxen
Lipoxen plc is a biopharmaceutical company focused on the development of new and improved biologic drugs and vaccines. Lipoxen has three proprietary patented technology platforms:
1) PolyXen - for extending the efficacy and half life of biologic drugs
2) ImuXen - for creating new vaccines and improving existing vaccines
3) SiRNAblate - for the delivery of siRNA
Lipoxen's technology is designed to improve the efficacy, safety, stability, biological half-life and immunologic characteristics of its products. Lipoxen has multiple drug and vaccine programmes in development. Two products are in clinical development, SuliXen, a long acting insulin and ErepoXen, a long-acting erythropoietin (EPO). Lipoxen's preclinical pipeline includes vaccines against HIV, influenza and malaria and Factor VIII through an exclusive license with Baxter, the global healthcare company.
The Company has a low-risk business model and out-licenses its proprietary technologies to biopharmaceutical companies that have strong manufacturing and marketing capabilities. Lipoxen currently has commercial agreements with some of the world's leading biotechnology and pharmaceutical companies including Baxter, Schering-Plough, Sanofi-Aventis, the Serum Institute of India Limited, Genentech, Amgen and Genzyme. Furthermore, Baxter led the £2.9 million fundraising that the Company announced in May 2009, with a US$1 million investment.
Lipoxen, which was founded in 1997, now trades on the AIM Market of the London Stock Exchange under the ticker symbol LPX. More information can be found at the Company's website: www.lipoxen.com.
CHAIRMAN'S STATEMENT
I am delighted to be able to update you on Lipoxen's progress. My last report (5th May 2009) predated a successful fund raising completed in late-May this year which generated gross new funds before expenses of £2.9m. The new capital was raised at a price of 8.5p per share by means of a Placing led by Noble and Company (Lipoxen's lead broker) and further supported by Singer Capital Markets (the Company's co-broker and NOMAD). The Placing was "cornerstoned" by Baxter International Inc. (our longest standing license partner) who invested US$1m (circa UK£0.63m) and is now our third largest shareholder with an equity holding of circa 4.8%. Management contributed some £0.36m of new capital with the balance of funds (£1.91m) being raised from a range of City and Swedish financial institutions. The new funds were raised against a continuing background of financial uncertainty in the City and a degree of institutional investor disenchantment with the AIM and small cap sector in general given the significant liquidity issues in other than "Big Board" stocks both in the UK and elsewhere. It is therefore a tribute to the inherent quality of Lipoxen's technology and programs that the funding was concluded with relative ease, at a reasonable price (as compared to some other secondary fundings at the time which were done at very substantial discounts to prevailing market prices) and in such a timely manner. The new capital has positioned the Company to better execute its business plan over the upcoming 12-18 months and, while management must continue to husband the Company's cash resources very carefully, the new capital has made certain preferred initiatives possible to undertake sooner rather than later.
In my most recent report I took the opportunity of offering a detailed review of the business since its Admission to AIM in January 2006 - a period in which very substantial positive technical development of our core patent-protected PolyXen and ImuXen platform technologies took place. I am pleased to now update shareholders as follows:
Baxter Factor VIII License Partner
Earlier this year the Company concluded its scope of work for the characterisation and optimisation of this important product candidate, with Baxter themselves taking in-house the final stage of development prior to the targeted nomination of a Product Candidate in H1-2010. While we do not expect to be advised of the attainment of this status until Q1/Q2 next year, we remain confident that our PolyXen technology is meeting, and will continue to meet, the performance targets set by Baxter such that the nomination will eventuate in the indicated timeline.
ErepoXen (long-acting erythropoietin/"EPO")
Our EPO product candidate, which is being taken through the clinic by the Serum Institute of India ("Serum", a circa 22% equity shareholder of Lipoxen), successfully completed Phase I trials earlier this year as announced on 6th May 2009. While the product candidate was expected to move into a Phase II(a) trial in India by the end of Q2-09, the Company has since been informed by Serum that they are sufficiently satisfied with the results to date that they have decided to move into a full Phase II program with a new CRO (Clinical Research Organisation) in order to shorten the overall time line required to bring the product to market in the developing world at the earliest possible date - currently expected to be mid-2013. While, prima facie, this appears perhaps to be a delay in the project, the reality is that it further underpins Serum's commitment to it by their entering into the next stage of clinical trials on a more challenging and greatly more costly basis. The Company is delighted that our partner has taken such decision and we remain confident that our product candidate will continue to perform well as it progresses through the clinic. The first patient dosing on the re-based Phase II trial is expected to occur in early January 2010 with initial results due in Q4-2010.
Serum remains the lead on the proposed Canadian Phase II(a) regulated trial but, in consideration of their decision to proceed to more robust Indian trials they have informed the Company that they prefer to pend the start of the Canadian trial until they have the expected level of positive indications from their Phase II trials in India.
Serum and FDS Pharma ("FDS", our principal shareholder with circa 28% equity holding) have also concluded a Memorandum of Understanding under which FDS will take the EPO candidate through a Russian Phase II trial with a view to getting the product to market in the former Commonwealth of Independent States (CIS) in 2012. It is notable that the Russian Federation has recently announced its decision to make such quantum of investment as is consistent with making the CIS substantially less dependent upon imported supplies of the more expensive biologic and vaccine drugs by making substantial monetary grants to qualifying domestic companies with the technological capabilities required to bring forward domestic biosimilars and vaccines. This policy has considerable potential to enhance Lipoxen's ability to work even more closely with FDS (and its partner CIS companies) on the development of product candidates for both biologics and vaccines whereby new candidates can be fast-tracked through to market in a much-shortened time period than is required for the completion of FDA/EMEA clinical trials. We will be looking at ways to capitalise on this efficient clinical process that would allow early and cost effective proof of concept on a number of potential candidates.
SuliXen (long-acting insulin/"INS")
Having successfully completed Phase I clinical trials as announced by the Company on 9th March 2009, Phase II trials of SuliXen are now expected to commence in Russia in early Q4 this year with results due end Q3-2010/early Q4-2010.
In conjunction with Glide Pharmaceuticals, the Company is also looking at novel approaches for the delivery of insulin in a needle-free manner. We are also actively analysing a broadening of the therapeutic scope of our SuliXen product and expect to report on both of these initiatives in Q1-2010.
Vaccines (ImuXen)
On 13th May 2009, the Company announced that it had entered into a pre-clinical project with the PATH Malaria Vaccine Initiative (PATH MVI) and the US National Institute of Allergy and Infectious Diseases (US NIAID) to determine the ability of Lipoxen's proprietary liposomal technology to stimulate enhanced immune responses against malaria protein. This is an important humanitarian initiative upon which the Company still plans to report in Q2-2010.
The further application of Lipoxen's ImuXen technology to the development of a novel HIV vaccine formulation funded by the Bill and Melinda Gates International Aids Vaccine Initiative (IAVI) commenced later than first expected in Q2 this year and is now expected to report in Q1-2010. This is another potentially important humanitarian initiative, and, while disappointing, the delay in reporting is not viewed by the Board as material.
siRNAblate (gene silencing)
In June we were pleased to announce that the Company had entered into a new technology evaluation agreement with an un-named Large Pharma company for the use of Lipoxen's siRNAblate technology to evaluate the effectiveness of combining the Pharma company's proprietary siRNA with Lipoxen's platform technology. The aim of the collaboration is to enhance the efficacy of the siRNA via our siRNAblate delivery. The evaluation is expected to be completed in Q4 this year and, if successful, could lead to a full development and licensing agreement.
The generally recognised major problem with the Nobel Prize-winning interfering RNAi technology is the ability to deliver the RNA intact to the targeted cells. While still at a very early stage of development, Lipoxen's siRNAblate technology has already shown promising results in a pre-clinical trial with its ability to overcome this otherwise rather intractable delivery issue.
Intellectual Property
The Company views the protection of its IP position as crucial to the building of long term shareholder value and expects to invest heavily in this area as our proprietary technologies continue through the development process.
A truly important step was achieved in June this year when Lipoxen's co-Delivery DNA Vaccine Patent was granted in the EU and the United States. This is a core part of the Company's IP asset portfolio and looks to the very heart of our vaccine platform technology. We are, therefore, extremely pleased to have attained this important milestone.
Progress with Collaborations
Our collaborations remain core to the Company's growth strategy as we seek to expand the application of our platform technologies with Big Pharma and Big Bio. I set out below a brief review on current collaborations:
Baxter International Technical progress continues to be made and we hope to see the
nomination of a Factor VIII lead Product Candidate in H1-2010.
Technology Strategy Board The Company's H1N1 Influenza product candidate was first
established as a project funded by the UK Technology Strategy
Board (TSB) working alongside Cambridge Biostability Limited
(CBL), the UK Health Protection Agency (HPA) and Cambridge
University (CUMIC). In June this year CBL was placed into a
Creditors Voluntary Liquidation which placed the project in some
temporary difficulty while the remaining parties worked out what
best to do. I am extremely pleased to advise that the project
has been reinitiated with Lipoxen as the lead and with a strong
focus on our H1N1 influenza candidate. The end-point of the new
project is the "Completion of protective efficacy studies with
stability sample" which, although perhaps up to 12 months away,
in view of the potential importance of the product, has been
given a high priority such that I expect that the Company will
be reporting results to the market in no more than 9 months from
now.
While the demise of CBL has obviously resulted in some delay,
with Lipoxen as the "lead" going forward, your Company is better
able to dictate the speed at which this project will advance and
is committed to claw back as much as possible of the past delays
for which Lipoxen had neither responsibility nor control.
Barbara Davis This project is designed to assess whether or not Lipoxen's
SuliXen product has the potential to treat, reverse or prevent
the underlying causes of Type 1 diabetes. The Barbara Davis
Centre of Childhood Diabetes is one of the world's leading
institutes in the field whose research work is applied both to
children and adults. The project has now been running for
several months and is expected to report in early Q4.
IAVI As noted (ante) this project remains on track to report in
Q1-2010. Notwithstanding that the HIV virus itself is a
powerfully mutating organism which represents a serious
challenge to any proposed prophylactic vaccine, the end point of
the project is the efficacy of the liposomal co-delivery
platform in generating efficacious levels of both cell-mediated
and immune system responses.
PATH MVI Also previously mentioned above, and with essentially the same
performance end-points as for IAVI, this program is expected to
report on time in Q2-2010.
University of Nottingham This program, for the improved delivery of antiviral drugs for
the treatment of liver disease caused by Hepatitis C is nearing
completion and we remain confident of being able to report on it
before the end of 2009.
Glide Pharmaceuticals In collaboration with Glide, the Company is continuing to drive
the development of the delivery of our long-acting insulin in
Glide's needle-free injector. This unique technological
combination has the potential to address a circa US$12b market.
We expect to provide an update before the end of this calendar
year
Angel Bioscience The Company continues to work on the incorporation of its
PolyXen technology into Angel's GCSF compound with a view to
being able to generate a Polysialated-GCSF with much improved
performance in the treatment for neutropenia, being the
treatment of patients whose white blood cell count becomes
seriously challenged pursuant to chemotherapy treatment. The
Company is also looking at broadening the therapeutic
application of a Polysialated-GCSF candidate and will report
further in Q1-2010.
Senior Management Appointment
In September 2009, the Company engaged the services of Dr David Moss as Director of Project Management.
Dr Moss has almost thirty years of research, development and project management experience gained from roles in both academia and the private biotech sector. His focus during this period has been on the development of vaccines for veterinary and human applications. He joins Lipoxen from Cambridge Biostability Limited (CBL) where he was Director of Research and was responsible for the company's entire research program focused on the development of thermostable vaccines and biopharmaceuticals. This included the Technology Strategy Board-funded vaccine project. Prior to CBL, he was Project Manager at Intervet UK (now Intervet Schering-Plough), a global veterinary vaccine and research and development company.
Your Board considers this to be an important appointment as the Company engages in more commercial contracts and seeks to further develop its proprietary product pipeline.
Summary and Outlook
The nature of Lipoxen's business model tends towards projects which extend for many months, or even years. It is therefore not always possible to report to shareholders in terms other than that Lipoxen's business development strategy continues to be executed as previously reported and that the Board remains confident that its corporate goals remain achievable in time frames consistent with the nature of the business.
* Our Baxter collaboration has moved to the next level and we are confident of their being able to nominate a lead Product candidate within the next 6-9 months.
* While the PolyXen platform has seen no new product candidates entering into clinical development in the period under review, our scientists continue to develop the underlying IP in the extant applications, being, Baxter's Factor VIII, and the SuliXen and EPO proprietary products. While the Company is evaluating a large number of prospective candidates, your Board is conscious of the need to find the shortest and most efficacious route to monetisation of the IP and, to that end, we are committing more management resource to risk assessment before a new project can gain approval for commencement and are actively enhancing our project management systems for its efficient delivery once authorised.
* Our ImuXen platform continues to generate much interest in both vaccine and siRNA applications. The Board believes that we will bring one or more product candidates to Phase I trials within 6-9 months, either directly or, preferably, funded either by a sovereign government or leading commercial partner.
* The Company's cash position has been substantially strengthened through the raising of circa £2.7m (net) in May by which means Management can, at the very least, "maintain course and speed" towards the monetisation of the company's proprietary IP which will be exemplified by the attainment of cash flow positivity through new license transactions with Big Pharma and/or Big Bio.
Financial Review
The financial results for the Group in the period under review were:
Six months Six months Year
to to to
30/06/09 30/06/08 31/12/08
Unaudited Unaudited Audited
£'000 £'000 £'000
Turnover 411 416 1,160
Total pre-tax losses for period 1,433 1,962 3,791
Non-cash component of total pre-tax loss 217 894 2,142
Net cash at end of period 2,797 1,213 602
Net asset value at the end of the period 4,289 4,596 2,973
pence pence pence
Loss per share - basic and fully diluted 1.14 1.51 2.89
Net asset value per share - basic 2.78 3.84 2.48
Net asset value per share - fully diluted 2.69 3.65 2.38
Non-cash component of total pre-tax losses: £'000 £'000 £'000
Depreciation of owned assets 137 133 275
R&D costs - equity settled 75 697 1,773
Share option expense - equity settled 5 64 94
Total principal non-cash items 217 894 2,142
Research and development - cash settled Note (1) 934 1,046 2,004
Other expenses - cash settled Note (2) 696 489 879
Total expenses - cash settled 1,630 1,535 2,883
Total non-cash items Note (3) 217 894 2,142
Total administrative expenses 1,847 2,429 5,025
% % %
Research and development - cash settled 57.3 68.1 69.5
Other expenses - cash settled 42.7 31.9 30.5
Total expenses - cash settled 100.0 100.0 100.0
NOTES
1. The rate of expenditure in this area has been relatively constant in the last 18 months. The reduction
this time is mainly comprised of a reduced level of external research costs compared to the same period
in 2008.
2. These costs have increased primarily due to:
a. The opening in January of this year of the Company's corporate offices as
administration space at the laboratories was no longer adequate.
b. Increases in audit, legal and regulatory costs.
c. PR costs associated with the fundraise concluded in May as well as a step change
in the Company's PR-facing activities as we need to better and more proactively
promote both our pre-clinical and clinical successes to more effectively raise
the profile of the business.
3. The substantial reduction here reflects the reduced charge to the Income Statement relating to the
SuliXen candidate which has now largely attained the milestones related to the prepaid value being
written off progressively as the product candidate has advanced from pre-clinical through the
successful completion of unregulated Phase I trials. The balance of the value currently held in the
Balance Sheet is expected to be expensed in H2 this year as the SuliXen product enters regulated
trials.
Trading conditions in the sector remain challenging. There has been continuing consolidation at the top end of the industry and feverish M&A lower down as some of our small-cap competitors find that raising new cash is almost impossible and are faced with few alternatives but to be acquired by larger companies with stronger balance sheets. A corollary to this scenario is that, while "Big Pharma/Bio" is awash with cash it is placing ever more demanding technical hurdles for the smaller companies to clear before they will enter into license discussions. The effect of this is that short term feasibility studies are not generating the levels of cash income seen even as recently as 2008, with the consequence that "small cap" companies such as Lipoxen are under continual pressure, not just to make efficiency savings wherever possible (clearly a "generally regarded as sensible" commercial stance) but to be highly cautious about taking on new projects with high performance risk characteristics. In that latter regard, your Company's technical offering on the PolyXen platform is relatively low risk; the ImuXen platform for vaccine candidates (especially for DNA co-delivery projects) currently might be characterised as having a relatively higher risk than PolyXen, mainly by virtue of our not yet having been able to take a new product candidate into the clinic. While the siRNA application of our liposomal entrapment technology remains very early stage - being entirely reasonable given the newness of the entire siRNA field - Lipoxen has already proved in pre-clinical trials that its siRNAblate technology can be highly effective in the knockdown of the "bad" cholesterol gene.
Our portfolio of proprietary technologies continues to attract interest from an ever-increasing list of partners, so, once more I believe that the coming months should deliver further tangible progress for the Company and I look forward to updating you on our developments in my next report.
Brian Richards, CBE
Non-Executive Chairman
London: 30th September 2009
CONDENSED CONSOLIDATED INCOME STATEMENT
FOR THE SIX MONTHS ENDED 30th JUNE 2009
Six months Six months Year
to to To
30/06/09 30/06/08 31/12/08
Unaudited Unaudited Audited
Note
£ £ £
REVENUE 4 411,097 415,968 1,160,324
ADMINISTRATIVE EXPENSES
Research and development 1,008,861 1,743,287 3,776,636
expenditure
Administrative expenses 838,556 685,529 1,247,817
Total 1,847,417 2,428,816 5,024,453
OPERATING LOSS (1,436,320) (2,012,848) (3,864,129)
Finance income 3,280 51,174 72,926
Finance costs - - -
LOSS BEFORE TAXATION (1,433,040) (1,961,674) (3,791,203)
Income tax credit - 157,916 332,916
LOSS FOR THE YEAR ATTRIBUTABLE (1,433,040) (1,803,758) (3,458,287)
TO EQUITY HOLDERS OF THE
PARENT
Loss per share - basic and 6 (1.14)p (1.51)p (2.89)p
fully diluted
CONDENSED CONSOLIDATED BALANCE SHEET AS AT 30th JUNE 2009
As at As at As at
30/06/09 30/06/08 31/12/08
Note Unaudited Unaudited Audited
£ £ £
NON-CURRENT ASSETS
Property, plant and equipment 548,864 769,586 665,972
Goodwill 1,061,476 1,061,476 1,061,476
1,610,340 1,831,062 1,727,448
CURRENT ASSETS
Trade and other receivables 7 468,740 1,764,324 1,118,559
Cash and cash equivalents 2,796,603 1,213,476 602,065
3,265,343 2,977,800 1,720,624
CURRENT LIABILITIES
Trade and other payables (586,299) (212,479) (474,849)
NET CURRENT ASSETS 2,679,044 2,765,321 1,245,775
NET ASSETS 4,289,384 4,596,383 2,973,223
EQUITY ATTRIBUTABLE TO EQUITY
HOLDERS OF THE PARENT
Share capital 8 2,403,790 2,231,468 2,232,790
Share premium account 25,081,916 22,508,165 22,508,793
Reverse acquisition reserve (8,252,127) (8,252,127) (8,252,127)
Accumulated losses (14,944,195) (11,891,123) (13,516,233)
TOTAL EQUITY 4,289,384 4,596,383 2,973,223
Net assets per share - basic 9 2.78p 3.84p 2.48p
Net assets per share - fully 9 2.69p 3.65p 2.38p
diluted
CONDENSED CONSOLIDATED CASH FLOW STATEMENT
FOR THE SIX MONTHS TO 30th JUNE 2009
Six months Six months Year
to to to
30/06/09 30/06/08 31/12/08
Note Unaudited Unaudited Audited
£ £ £
Cash flows from operating 5 (532,961) (1,405,932) (2,177,421)
activities
Interest received 3,280 51,174 72,926
Taxation received - 157,916 332,916
Net cash outflow from operating (529,681) (1,196,842) (1,771,579)
activities
Cash flows from investing
activities
Purchase of property, plant and (19,904) (35,618) (74,242)
equipment
Cash flows from financing
activities
Issue of equity share capital 2,744,123 - 1,950
Net increase/(decrease) in cash 2,194,538 (1,232,460) (1,843,871)
and cash equivalents
Cash and cash equivalents at 602,065 2,445,936 2,445,936
beginning of year
Cash and cash equivalents at 2,796,603 1,213,476 602,065
end of year
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN NET EQUITY
FOR THE SIX MONTHS TO 30th JUNE 2009
Reverse
Share Share premium Acquisition Accumulated
capital reserve losses
Total
£ £ £ £ £
At 1st January 2008 2,231,468 22,508,165 (8,252,127) (10,151,635) 6,335,871
Loss for six months ended 30th
June 2008 - - - (1,803,758) (1,803,758)
Share-based payments - - - 64,270 64,270
At 30th June 2008 2,231,468 22,508,165 (8,252,127) (11,891,123) 4,596,383
Loss for six months ended 31st
December 2008 - - - (1,654,529) (1,654,529)
Shares issued for cash 1,322 628 - - 1,950
Share-based payments - - - 29,419 29,419
At 31st December 2008 2,232,790 22,508,793 (8,252,127) (13,516,233) 2,973,223
Loss for six months ended 30th
June 2009 - - - (1,433,040) (1,433,040)
Shares issued for cash 171,000 2,736,000 - - 2,907,000
Share issue expenses - (162,877) - - (162,877)
Share-based payments - - - 5,078 5,078
At 30th June 2009 2,403,790 25,081,916 (8,252,127) (14,944,195) 4,289,384
LIPOXEN PLC
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
FOR THE SIX MONTHS TO 30th JUNE 2009
1. GENERAL INFORMATION
The interim financial statements for the six months ended 30th
June 2009 are unaudited and were approved by the Directors of
the Company on 30th September 2009. The condensed financial
information set out above does not constitute statutory accounts
within the meaning of Section 434 of the Companies Act 2006. The
comparative figures for the year ended 31st December 2008 were
derived from the statutory accounts for that year which have
been delivered to the Registrar of Companies. Those accounts
received an unqualified audit report, which included a reference
by way of emphasis without qualifying the report to the
preparation of the accounts on the going concern basis of
accounting. The audit report contained no statements under
sections 237(2) or (3) (accounting records or returns
inadequate, accounts not agreeing with records and returns, or
failure to obtain necessary information and explanations) of the
Companies Act 1985.
The financial information has been prepared in accordance with
the accounting policies set out below. The accounts are drawn up
in compliance with IAS 34 "Interim Financial Reporting".
2. ACCOUNTING POLICIES
The principal accounting policies of the Group have remained
unchanged from those set out in the Group's 2008 financial
statements.
Fundamental accounting concept - going concern
As an early-stage development life sciences business, the Group
has incurred operating losses in the period under review,
notwithstanding that substantial clinical and technical progress
was also made in the continuing successful development of its
proprietary technologies; consequently, the Group was a net
consumer of cash.
In order to maintain the level of scientific effort required to
develop the Group's technologies and to commercialise them to
such degree as will be necessary to become a cash-generative
business, the Group will need to access new cash in addition to
that available to it at the period end; such new cash will
either be generated internally from, as yet, non-contractual
feasibility and licensing sources and/or from the raising of new
capital.
The Directors have prepared a financial forecast for the period
through to 31st December 2011. The forecast includes assumptions
that the Group will generate cash inflows in this period from:
a. the ongoing roll-out
and licensing of the
Group's technologies
with its existing
collaborative
partners;
b. the roll-out and
licensing of the
Group's technologies
with new
collaborative
partners; and
c. the raising of new
capital.
In May 2009 the Company successfully raised new capital of £2.9m before expenses - notwithstanding continuing uncertainties in the capital markets (given the ongoing global financial difficulties) especially for small cap companies. The Board was very much encouraged by that success which they consider as a positive endorsement of their underlying confidence in the economic prospects for monetisation of the
Company's core IP in protein drug development, novel vaccines and gene silencing technologies; that said, markets remain volatile and, should it prove necessary, the Company's ability to raise further new capital will remain dependent upon prevailing market conditions at the time.
While considering that platform technology applications to known and marketed drugs confer lower commercial risks than in new drug development, the Directors recognise that there are uncertainties surrounding these core issues.
If the Group was to prove unable to generate these additional cash inflows, the cash balance of c
3. SEGMENTAL ANALYSIS
The revenue and loss before tax are attributable to the one principal activity of the Group. The net assets of the Group at 30th June 2009, 31st December 2008 and 30th June 2008 are wholly attributable to the principal activity. The Group comprises one business segment for reporting purposes.
4. REVENUE
An analysis of revenue (by location of customer) is given below:
Six months Six months Year
to to to
30/06/09 30/06/08 31/12/08
Unaudited Unaudited Audited
£ £ £
United States 262,149 339,790 1,060,636
Europe 148,948 76,178 99,688
411,097 415,968 1,160,324
5. RECONCILIATION OF LOSS BEFORE TAXATION TO
CASH OUTFLOWS FROM OPERATING ACTIVITIES
Six months Six months Year
to to to
30/06/09 30/06/08 31/12/08
Unaudited Unaudited Audited
£ £ £
Loss before taxation (1,433,040) (1,961,674) (3,791,203)
Adjustments for:
Equity-settled share options 5,078 64,270 93,689
Equity-settled research and development 75,000 697,257 1,773,126
Depreciation 137,012 132,584 274,822
Investment income (3,280) (51,174) (72,926)
(1,219,230) (1,118,737) (1,722,492)
Decrease/(increase) in receivables 574,819 (205,941) (636,045)
Increase/(decrease) in payables 111,450 (81,254) 181,116
Net cash outflow from operating activities (532,961) (1,405,932) (2,177,421)
6. LOSS PER SHARE
Six months Six months Year
to to to
30/06/09 30/06/08 31/12/08
Unaudited Unaudited Audited
£ £ £
Weighted average number of ordinary shares in issue 126,093,444 119,593,552 119,668,535
Loss after taxation 1,433,040 1,803,758 3,458,287
Loss per share 1.14p 1.51p 2.89p
There is no dilutive effect of share options on the basic loss per share.
7. OTHER RECEIVABLES
In October 2005, Lipoxen Technologies Limited entered into an agreement with its then major shareholder, FDS Pharma Ass ('FDS'), under which 15,000,000 ordinary shares were allotted in consideration for the provision by FDS of manufacturing and clinical development services. As per a Novation Agreement between FDS, Lipoxen Technologies Limited and the Company dated 16th
January 2006, the agreement provides for the allotment of up to 10,174,340 ordinary shares in Lipoxen Plc upon achievement of certain future milestones to the financial value of US$2,670,764 as approved by shareholders at the Extraordinary General Meeting of the Company held on 16th January 2006. An amount of £75,000 (6 months to 30/06/08 - £697,257; year to 31/12/08
-£1,773,126) has been charged to the income statement in the period in respect of services provided by FDS. An amount of £236,725 (30/06/08 - £1,387,594; 31/12/08 - £311,725) is included in the balance sheet under other receivables in respect of services still to be provided und
8. SHARE CAPITAL
The changes in the Company's issued share capital in the period have been as follows:
Ordinary shares of 0.5p Deferred shares of 0.01p Total
Number £ Number £ £
At 1st January 2009 119,858,085 599,290 16,335,000,000 1,633,500 2,232,790
Shares issued for 34,200,000 171,000 - - 171,000
cash
At 30th June 2009 154,058,085 770,290 16,335,000,000 1,633,500 2,403,790
In May 2009, the Company issued 34,200,000 ordinary shares by way of a placing. The shares were priced at 8.5p per share and raised £2,744,123 net of expenses
9. NET ASSET VALUE PER SHARE
The "basic" net asset value per share figures are calculated on the basis of the net assets attributable to equity shareholders divided by the number of ordinary shares in issue at the relevant dates.
The "fully diluted" net assets per share figures are calculated by adjusting the number of ordinary shares on the assumption of the exercise in full of all options and warrant instruments extant as at the relevant dates where the exercise price of any such instrument is less than the "basic" net asset value per s hare.
10. Copies of the interim report are available to the public free of charge from the Company at London Bioscience Innovation Centre, 2 Royal College Street, London, NW1 0NH during normal office hours, Saturdays and Sundays excepted, for 14 days from today.
This information is provided by RNS
The company news service from the London Stock Exchange
END
IR LMMMTMMIJBLL
More |
||
| Date/Time | Subject | Author | ||
|---|---|---|---|---|
| Sat 01:10 |
BUY
mastertrader987
|
1
|
||
|
| ||||
|
| ||||
|
Sink me you cheeky fellow. Beg to disagree. I passionatly believe in the potential of Lipoxen - based on my reasearch aided by by respected regulars on this BB.
I am not surprised your opINION is not supported by one ounce of reasoned argument. td2 Aand others posts provide a sterling auditable record for the case for a long term invstement here. Please excuse my annoyance at the mastetrader post- I truly believe this a quality risk/reward long term investment- The potential here is fantastic I would not normally rise to the bait but I have imbibed of the fluid that I esteem most highly. Have a good weekend - and enjoy the LPX bb whilst is is under the idiots radar I bid you good day MW More | View thread (1) | Respond | Login to Vote up | Login to Vote down |
||||
| Tue 09:36 | ||||
|
| ||||
|
| ||||
|
Nothing we don't already know.
http://www.proactiveinvestors.com/companies/news/2992/lipoxen-in-research-collaboration-with-russias-pharmsynthez-2992.html A good write up anyway. TDT  More | View thread (1) | Respond | Login to Vote up | Login to Vote down |
||||
| Mon 19:05 |
2
|
|||
|
| ||||
|
| ||||
|
Check out this posters history, says it all.
More | View thread (4) | Respond | Login to Vote up | Login to Vote down |
||||
| Mon 19:01 |
6
|
|||
|
| ||||
|
| ||||
|
This is another loser. Complete dog. Sell at best while the broker will take the order. Why the hell did I waste money on this one?
More | View thread (4) | Respond | Login to Vote up | Login to Vote down |
||||
They have not been approved or issued by Interactive Investor Trading Limited.
Discussion Board Terms & Conditions FSA Market Abuse Fact Sheet
More...